CLASS II ONGOING Drug recall · Reported 12 Apr 2023 · FDA Enforcement Report

Alprazolam C-IV, 1 mg recalled by Direct Rx

Direct Rx is recalling Alprazolam C-IV, 1 mg, distributed nationwide in the US. The recall was initiated on 22 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.

Quantity recalled349 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0508-2023
FDA event ID: 92054
Recalling firm: Direct Rx, Dawsonville, GA
Classification: Class II
Status: Ongoing
Recall initiated: 22 Mar 2023
FDA classified: 6 Apr 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Anxiety & Sleep Medication

Timeline

22 Mar 2023	Recall initiated by company
6 Apr 2023	Classified by FDA	+15 days
12 Apr 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Product as listed by the FDA

Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Which lots are affected?

Lots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 92054

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023	CLASS II	Alprazolam C-IV, 2 mg, 60 Tabs recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Alprazolam C-IV, 0.5 mg, 30 Tabs recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Direct Rx

All 37

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Duloxetine D/R, a) 30 mg recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
23 Apr 2025Drug	CLASS II	Ciprofloxacin Ophth Solution recalled by Direct Rx	Direct Rx	Packaging Defects	5 states
13 Nov 2024Drug	CLASS II	Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled	Direct Rx	Potency & Assay	Nationwide

Other Alprazolam C-iv recalls

All 5

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023Drug	CLASS II	Alprazolam C-IV, 0.5 mg, 30 Tabs recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Alprazolam C-IV, 2 mg, 60 Tabs recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
16 Mar 2022Drug	CLASS II	Alprazolam C-IV 2 mg recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	FL, GA, LA
16 Mar 2022Drug	CLASS II	Alprazolam C-IV 1 mg recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	FL, GA, LA